HIVNCT05600621
Suubi+Adherence4Youth
A study testing Financial Literacy Training (FLT) Workshops, Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) and A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). in people with HIV, run by Washington University School of Medicine at 1 site in Uganda.
Trial summary
The study will test four economic empowerment intervention components to identify the combination that best enhance viral suppression. The study design is a 2-to-the 4 factorial experiment. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- HIV
- What is being tested?
- Financial Literacy Training (FLT) Workshops, Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) and A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 1 siteUganda
- Study dates
- 26 Jun 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescent:
- living with HIV (confirmed by medical report and aware of status)
- living within a family
- being 11-17 years of age (at enrollment)
- prescribed ART
- enrolled in ART care at one of the 48 health clinics in the study districts.
Show all 9Show fewer
- Health clinics would be eligible if they:
- have existing procedures tailored to adolescent adherence (including adolescent-specific clinic days and peer counselling)
- Accredited by the Uganda Ministry of Health as a provider of ART within the study districts.
Who cannot join
- Includes an inability to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent or parent.
- If the adolescent or adult caregiver presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suubi+Adherence4Youth: Optimizing the Suubi Intervention for Adherence to HIV Treatment for Youth Living With HIV in Uganda
The study will test four economic empowerment intervention components to identify the combination that best enhance viral suppression.
The study design is a 2-to-the 4 factorial experiment. The 2 represents the level of each component:0 (receive) or (don't receive) four components: 1) Financial Literacy Training (FLT); 2) Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); 3) A manualized intervention for ART adherence and stigma reduction (Suubi Cartoon); and 4) Engagement with HIV treatment-experienced role models who share their lived experiences of HIV. Guided by the MOST framework, the study will test each of the four components' performance and their combinations on the primary outcome, viral suppression. Resulting in 16 unique conditions representing all possible combinations of the 4 components. The study will randomize at the level of health clinics (N=48). Clinics will be randomized to provide one of the 16 conditions, with 12 ALHIV (aged 11-17 years) enrolled per clinic, yielding main effects and interaction effects for the 4 components on sustained viral suppression. Sustained viral suppression is defined as an undetectable viral load on all 12-, 24- and 36-month follow-up assessments.
Read the detailed description
The number of adolescents living with HIV (ALHIV) in Uganda is over 170,000 and growing. Ugandan ALHIV are a priority due to social and structural inequities that make them highly vulnerable to HIV infection and sub-optimal access and adherence to antiretroviral therapy (ART). Less than 50% of ALHIV in Uganda are ART-adherent leading to low rates of viral suppression and high rates of attrition from HIV care. In response to the call for expanding differentiated care approaches for ALHIV and new forms of combination HIV interventions, we seek to intervene on social and structural inequities as economic and psychosocial hardships exacerbate the risk for viral load non-suppression. Addressing these hardships can improve the livelihoods of ALHIV and give them the knowledge and resources to sustainably manage HIV.
With 15+ years of intervention research combining 1) economic empowerment (EE) and 2) psychosocial components for HIV prevention, care and support for adolescents in SSA, we have demonstrated the effectiveness of Suubi (Hope), our multi-component combination intervention tested in four RCTs in Uganda (R01HD070727, R01HD074949, R34MH081763, R01MH113486) and one foundation-funded study in Kenya. With EE components to address economic hardships and psychosocial components to address ART non-adherence and HIV stigma, we have improved viral suppression and psychosocial and mental health functioning. Suubi is evidence-based and theory-informed and has four components: 1) Financial Literacy Training (FLT); 2) Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); 3) A manualized intervention for ART adherence and stigma reduction (Suubi Cartoon); and 4) Engagement with HIV treatment-experienced role models who share their lived experiences of HIV. Suubi has shown robust effects on viral suppression and ART adherence, mental health, psychosocial outcomes, and family financial stability and cohesion. However, it is unknown if each component in Suubi had a positive effect, how the components interacted, or if fewer components could have produced equivalent effects. Given our successes and infrastructure, we are well-positioned to unpack and optimize Suubi to identify the most impactful and sustainable components for scale up across Uganda.
The study will use a factorial experiment to unpack, test, and optimize the Suubi intervention to enhance scale up in health systems using the multi-phase optimization strategy (MOST), an engineering-inspired intervention framework. Guided by the MOST framework, the study will test each of the four components' performance and their combinations in a fully powered efficient factorial experiment on the primary outcome, viral suppression. Then a pre-specified optimization objective will be set to create the new "optimized" intervention. We define our "optimization objective" as the most cost-effective components that addresses three real-world constraints (i.e., challenges to implementation): 1) efficiency (do the components work within our existing health systems?), 2) affordability (do observed effect sizes justify costs and labor?), and 3) scalability (do components perform exactly as they would at scale?). The study will evaluate various component combination effect sizes and balance them against real-world constraints and costing data to empirically arrive at optimization. Our goal is to build Suubi 2.0 (hereafter, Suubi+Adherence4Youth), a combination of components for viral suppression that meets standards for being efficient, affordable, and working at scale.
The study will be guided by the following specific aims:
Aim 1. Conduct a factorial experiment (optimization trial) to test the main effects of each of the four Suubi intervention components and combinations of components (interactions) on viral suppression (primary outcome);
Aim 2. Test mediators and explore moderators that explain and modify the relationship between each of the four Suubi intervention components and viral suppression;
Aim 3. Compare the cost and cost-effectiveness of each of the four Suubi intervention components and every combination of components.
- Conditions
- HIV
- Being tested
- Financial Literacy Training (FLT) Workshops, Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs), A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)., Engagement with HIV treatment-experienced role models who share lived experiences of HIV, Standard of Care (SOC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial Literacy Training (FLT) WorkshopsBehavioural
Participants will be assigned to receive FLT workshops which are implemented by community-level agencies in collaboration with the financial institutions. FLT comprises six workshops delivered over 6 weeks. Topics include: a) an introduction to the notion of asset-building; b) coverage of asset-building strategies in detail, e.g., saving; c) coverage of specific topics related to saving, e.g., the importance of saving and how to save, d) an introduction of banking services to participants and e) coverage of basics of borrowing and debt management. Participants from the same location, in this case, clinics are assigned to the same group. Workshops occur on weekends to accommodate participants week-day schedules, including school and/or gardening.
Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)Behavioural
ALHIV will receive a YSA with a 1:1 matched savings program at a financial institution accredited by the Bank of Uganda. Each YDA will be opened in the name of the adolescent, with their primary caregiver as a co-signer, until the adolescent turns 18 years. The account will then be matched with money from the program on 1:1 rate.
As part of YSA, ALHIV are also trained on investing in income-generating activities (IGA) and are normally allowed to use up to 30% of their matched savings to invest in an IGA to benefit their family. The IGA portion helps promote economic stability for families and enable the ALHIV to afford medical expenses.
A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).Behavioural
Participants assigned to this component will participate together with her/his caregiving family, in attending sixteen 60 minute sessions hosted within the community over 16 weeks. Each session involves 6-10 families. Participants will learn from the Suubi Cartoon curriculum about their HIV diagnosis and treatment needs, while coping with family loss, stigma, peer relationships, identity, and family functioning.
Engagement with HIV treatment-experienced role models who share lived experiences of HIVBehavioural
Participants will be assigned to small groups with an average of 3-4 peers from the same health clinic, and each ALHIV stays in the same group -- for 9 sessions - with the same role model. This is intended to build trust and rapport not only between the role model and mentee, but also between all group members. The 9 sessions, to be conducted over a 6-month period, include activities, videos, scenarios, and role-playing to facilitate discussion and learning. This is intended to promote their self-esteem, improve their HIV care engagement, reduce stigma and stress, encourage hopefulness, build stronger communication skills with their caregivers and/or family members, enhance safe sexual decision-making, and decrease sexual risk-taking behavior.
Standard of Care (SOC)Other
SOC consisting of pediatric ART initiation and monitoring outlined by Uganda's Ministry of Health.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1: Components 1, 2,3 and 4 | Experimental | Participants will be assigned to receive all of the four intervention programs:
1. Financial Literacy Training (FLT) Workshops
2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
3. A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
4. Engagement with HIV treatment-experienced role models who share lived experiences of HIV. Receives: Behavioral: Financial Literacy Training (FLT) Workshops; Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).; Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV |
| Condition 2: Components 1, 2 and 3 | Experimental | 1. Financial Literacy Training (FLT) Workshops
2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
3. A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) Receives: Behavioral: Financial Literacy Training (FLT) Workshops; Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). |
| Condition 3: Components 1, 2 and 4 | Experimental | 1. Financial Literacy Training (FLT) Workshops
2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. Receives: Behavioral: Financial Literacy Training (FLT) Workshops; Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV |
| Condition 4: Components 1 and 2 | Experimental | 1. Financial Literacy Training (FLT) Workshops
2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) Receives: Behavioral: Financial Literacy Training (FLT) Workshops; Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) |
| Condition 5: Components 1,3 and 4 | Experimental | 1.Financial Literacy Training (FLT) Workshops
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. Receives: Behavioral: Financial Literacy Training (FLT) Workshops; Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).; Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV |
| Condition 6: Components 1 and 3 | Experimental | 1.Financial Literacy Training (FLT) Workshops
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) Receives: Behavioral: Financial Literacy Training (FLT) Workshops; Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). |
| Condition 7: Components 1 and 4 | Experimental | 1.Financial Literacy Training (FLT) Workshops
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. Receives: Behavioral: Financial Literacy Training (FLT) Workshops; Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV |
| Condition 8: Components 1 | Experimental | 1.Financial Literacy Training (FLT) Workshops Receives: Behavioral: Financial Literacy Training (FLT) Workshops |
| Condition 9: Components 2,3 and 4 | Experimental | 2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. Receives: Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).; Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV |
| Condition 10: Components 2 and 3 | Experimental | 2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) Receives: Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). |
| Condition 11: Components 2 and 4 | Experimental | 2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. Receives: Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV |
| Condition 12: Components 2 | Experimental | 2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) Receives: Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) |
| Condition 13: Components 3 and 4 | Experimental | 3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. Receives: Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).; Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV |
| Condition 14: Components 3 | Experimental | 3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) Receives: Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). |
| Condition 15: Components 4 | Experimental | 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. Receives: Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV |
| Condition 16: No Components | Experimental | Participants not assigned to any of the 4 components Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Viral Suppression
Change in viral suppression will be assessed using viral load (VL) data collected from health clinic records. VL will be dichotomized between undetectable /suppression (VL< 40 copies/ml) and detectable/failed viral suppression (VL > =40 copies/ml) levels at each assessment time.
Measured: Baseline 12, 24 and 36 month follow-up
Cost-Effectiveness Analyses
Cost-effectiveness analyses measuring the cost of achieving an agreed upon benefit, such as cost of staff time, supplies, overhead of IDA's, as measured by admin review and project records.
Measured: Baseline 12, 24 and 36 month follow-up
Secondary outcomes (6)
Financial Literacy
Change in Financial Literacy knowledge will be measured using the Financial Literacy Knowledge item, with higher scores indicating higher financial literacy.
Measured: Baseline 12, 24 and 36 month follow-up
Financial management skills
Change in financial management skills will be measured using the Attitudes about Saving Scale, with higher scores indicating greater financial management skills.
Measured: Baseline 12, 24 and 36 month follow-up
Engagement with financial institutions
Change in engagement with financial institutions will be measured using the frequency of deposits and withdrawals by data from bank statements.
Measured: Baseline 12, 24 and 36 month follow-up
Change in confidence to save
Change in confidence to save will be measured using the Financial Literacy Knowledge item, with higher scores indicating higher confidence to save.
Measured: Baseline 12, 24 and 36 month follow-up
Change in motivation to save
Motivation to save will be measured using the Financial Literacy Knowledge item, with higher scores indicating higher motivation to save.
Measured: Baseline 12, 24 and 36 month follow-up
Change in savings amount and Investment in IGA
Change in savings amount and investment measured by data from bank statements
Measured: Baseline 12, 24 and 36 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start26 Jun 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The factorial experiment is guided by the Multiphase Optimization Strategy (MOST). The 4 intervention components are: Component 1. Financial Literacy Training (FLT); Component 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); Component 3. A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon); Component 4. Engagement with HIV treatment-experienced role models who share their lived experiences of HIV. Clinics will be randomized to provide one of the 16 conditions, with 12 ALHIV (aged 11-17 years) enrolled per clinic, yielding main effects and interaction effects for the 4 components on sustained viral suppression.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fred Ssewamala, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600621
- Sponsor's protocol ID
- R01MH131507
- Status last verified
- Jan 2026
- First submitted
- 5 Oct 2022
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per Code of Federal Regulations Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Washington University in St. Louis' Office of Sponsored Projects' data sharing agreement.
Publications
Ssewamala FM, Sauceda JA, Brathwaite R, Neilands TB, Nabunya P, Brown D, Sensoy Bahar O, Namuwonge F, Nakasujja N, Mugarura A, Mwebembezi A, Nartey P, Mukasa B, Gwadz M. Suubi + Adherence4Youth: a study protocol to optimize the Suubi Intervention for Adherence to HIV treatment for youth living with HIV in Uganda. BMC Public Health. 2023 Apr 20;23(1):717. doi: 10.1186/s12889-023-15564-4.
PubMed 37081534
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suubi+Adherence4Youth: Optimizing the Suubi Intervention for Adherence to HIV Treatment for Youth Living With HIV in Uganda
- ClinicalTrials.gov ID
- NCT05600621
- Acronym / sponsor ID
- R01MH131507
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, San Francisco
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will test four economic empowerment intervention components to identify the combination that best enhance viral suppression.
The study design is a 2-to-the 4 factorial experiment. The 2 represents the level of each component:0 (receive) or (don't receive) four components: 1) Financial Literacy Training (FLT); 2) Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); 3) A manualized intervention for ART adherence and stigma reduction (Suubi Cartoon); and 4) Engagement with HIV treatment-experienced role models who share their lived experiences of HIV. Guided by the MOST framework, the study will test each of the four components' performance and their combinations on the primary outcome, viral suppression. Resulting in 16 unique conditions representing all possible combinations of the 4 components. The study will randomize at the level of health clinics (N=48). Clinics will be randomized to provide one of the 16 conditions, with 12 ALHIV (aged 11-17 years) enrolled per clinic, yielding main effects and interaction effects for the 4 components on sustained viral suppression. Sustained viral suppression is defined as an undetectable viral load on all 12-, 24- and 36-month follow-up assessments.
Detailed description
The number of adolescents living with HIV (ALHIV) in Uganda is over 170,000 and growing. Ugandan ALHIV are a priority due to social and structural inequities that make them highly vulnerable to HIV infection and sub-optimal access and adherence to antiretroviral therapy (ART). Less than 50% of ALHIV in Uganda are ART-adherent leading to low rates of viral suppression and high rates of attrition from HIV care. In response to the call for expanding differentiated care approaches for ALHIV and new forms of combination HIV interventions, we seek to intervene on social and structural inequities as economic and psychosocial hardships exacerbate the risk for viral load non-suppression. Addressing these hardships can improve the livelihoods of ALHIV and give them the knowledge and resources to sustainably manage HIV.
With 15+ years of intervention research combining 1) economic empowerment (EE) and 2) psychosocial components for HIV prevention, care and support for adolescents in SSA, we have demonstrated the effectiveness of Suubi (Hope), our multi-component combination intervention tested in four RCTs in Uganda (R01HD070727, R01HD074949, R34MH081763, R01MH113486) and one foundation-funded study in Kenya. With EE components to address economic hardships and psychosocial components to address ART non-adherence and HIV stigma, we have improved viral suppression and psychosocial and mental health functioning. Suubi is evidence-based and theory-informed and has four components: 1) Financial Literacy Training (FLT); 2) Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); 3) A manualized intervention for ART adherence and stigma reduction (Suubi Cartoon); and 4) Engagement with HIV treatment-experienced role models who share their lived experiences of HIV. Suubi has shown robust effects on viral suppression and ART adherence, mental health, psychosocial outcomes, and family financial stability and cohesion. However, it is unknown if each component in Suubi had a positive effect, how the components interacted, or if fewer components could have produced equivalent effects. Given our successes and infrastructure, we are well-positioned to unpack and optimize Suubi to identify the most impactful and sustainable components for scale up across Uganda.
The study will use a factorial experiment to unpack, test, and optimize the Suubi intervention to enhance scale up in health systems using the multi-phase optimization strategy (MOST), an engineering-inspired intervention framework. Guided by the MOST framework, the study will test each of the four components' performance and their combinations in a fully powered efficient factorial experiment on the primary outcome, viral suppression. Then a pre-specified optimization objective will be set to create the new "optimized" intervention. We define our "optimization objective" as the most cost-effective components that addresses three real-world constraints (i.e., challenges to implementation): 1) efficiency (do the components work within our existing health systems?), 2) affordability (do observed effect sizes justify costs and labor?), and 3) scalability (do components perform exactly as they would at scale?). The study will evaluate various component combination effect sizes and balance them against real-world constraints and costing data to empirically arrive at optimization. Our goal is to build Suubi 2.0 (hereafter, Suubi+Adherence4Youth), a combination of components for viral suppression that meets standards for being efficient, affordable, and working at scale.
The study will be guided by the following specific aims:
Aim 1. Conduct a factorial experiment (optimization trial) to test the main effects of each of the four Suubi intervention components and combinations of components (interactions) on viral suppression (primary outcome);
Aim 2. Test mediators and explore moderators that explain and modify the relationship between each of the four Suubi intervention components and viral suppression;
Aim 3. Compare the cost and cost-effectiveness of each of the four Suubi intervention components and every combination of components.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 16
- Model description
- The factorial experiment is guided by the Multiphase Optimization Strategy (MOST). The 4 intervention components are: Component 1. Financial Literacy Training (FLT); Component 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); Component 3. A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon); Component 4. Engagement with HIV treatment-experienced role models who share their lived experiences of HIV. Clinics will be randomized to provide one of the 16 conditions, with 12 ALHIV (aged 11-17 years) enrolled per clinic, yielding main effects and interaction effects for the 4 components on sustained viral suppression.
| Arm | Type | Receives |
|---|---|---|
| Condition 1: Components 1, 2,3 and 4 | Experimental | Behavioral: Financial Literacy Training (FLT) Workshops, Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs), Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)., Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIVParticipants will be assigned to receive all of the four intervention programs: 1. Financial Literacy Training (FLT) Workshops 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) 3. A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) 4. Engagement with HIV treatment-experienced role models who share lived experiences of HIV. |
| Condition 2: Components 1, 2 and 3 | Experimental | Behavioral: Financial Literacy Training (FLT) Workshops, Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs), Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).1. Financial Literacy Training (FLT) Workshops 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) 3. A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) |
| Condition 3: Components 1, 2 and 4 | Experimental | Behavioral: Financial Literacy Training (FLT) Workshops, Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs), Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV1. Financial Literacy Training (FLT) Workshops 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. |
| Condition 4: Components 1 and 2 | Experimental | Behavioral: Financial Literacy Training (FLT) Workshops, Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)1. Financial Literacy Training (FLT) Workshops 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) |
| Condition 5: Components 1,3 and 4 | Experimental | Behavioral: Financial Literacy Training (FLT) Workshops, Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)., Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV1.Financial Literacy Training (FLT) Workshops 3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. |
| Condition 6: Components 1 and 3 | Experimental | Behavioral: Financial Literacy Training (FLT) Workshops, Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).1.Financial Literacy Training (FLT) Workshops 3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) |
| Condition 7: Components 1 and 4 | Experimental | Behavioral: Financial Literacy Training (FLT) Workshops, Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV1.Financial Literacy Training (FLT) Workshops 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. |
| Condition 8: Components 1 | Experimental | Behavioral: Financial Literacy Training (FLT) Workshops1.Financial Literacy Training (FLT) Workshops |
| Condition 9: Components 2,3 and 4 | Experimental | Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs), Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)., Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) 3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. |
| Condition 10: Components 2 and 3 | Experimental | Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs), Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) 3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) |
| Condition 11: Components 2 and 4 | Experimental | Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs), Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. |
| Condition 12: Components 2 | Experimental | Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) |
| Condition 13: Components 3 and 4 | Experimental | Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)., Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. |
| Condition 14: Components 3 | Experimental | Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) |
| Condition 15: Components 4 | Experimental | Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV. |
| Condition 16: No Components | Experimental | Other: Standard of Care (SOC)Participants not assigned to any of the 4 components |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- living with HIV (confirmed by medical report and aware of status)
- living within a family
- being 11-17 years of age (at enrollment)
- prescribed ART
- enrolled in ART care at one of the 48 health clinics in the study districts.
Key exclusion criteria (2 listed)
- Includes an inability to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent or parent.
- If the adolescent or adult caregiver presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial Literacy Training (FLT) WorkshopsParticipants will be assigned to receive FLT workshops which are implemented by community-level agencies in collaboration with the financial institutions. FLT comprises six workshops delivered over 6 weeks. Topics include: a) an introduction to the notion of asset-building; b) coverage of asset-building strategies in detail, e.g., saving; c) coverage of specific topics related to saving, e.g., the importance of saving and how to save, d) an introduction of banking services to participants and e) coverage of basics of borrowing and debt management. Participants from the same location, in this case, clinics are assigned to the same group. Workshops occur on weekends to accommodate participants week-day schedules, including school and/or gardening. | Behavioural | Condition 1: Components 1, 2,3 and 4, Condition 2: Components 1, 2 and 3, Condition 3: Components 1, 2 and 4, Condition 4: Components 1 and 2, Condition 5: Components 1,3 and 4, Condition 6: Components 1 and 3, Condition 7: Components 1 and 4, Condition 8: Components 1 |
| Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)ALHIV will receive a YSA with a 1:1 matched savings program at a financial institution accredited by the Bank of Uganda. Each YDA will be opened in the name of the adolescent, with their primary caregiver as a co-signer, until the adolescent turns 18 years. The account will then be matched with money from the program on 1:1 rate. As part of YSA, ALHIV are also trained on investing in income-generating activities (IGA) and are normally allowed to use up to 30% of their matched savings to invest in an IGA to benefit their family. The IGA portion helps promote economic stability for families and enable the ALHIV to afford medical expenses. | Behavioural | Condition 10: Components 2 and 3, Condition 11: Components 2 and 4, Condition 12: Components 2, Condition 1: Components 1, 2,3 and 4, Condition 2: Components 1, 2 and 3, Condition 3: Components 1, 2 and 4, Condition 4: Components 1 and 2, Condition 9: Components 2,3 and 4 |
| A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).Participants assigned to this component will participate together with her/his caregiving family, in attending sixteen 60 minute sessions hosted within the community over 16 weeks. Each session involves 6-10 families. Participants will learn from the Suubi Cartoon curriculum about their HIV diagnosis and treatment needs, while coping with family loss, stigma, peer relationships, identity, and family functioning. | Behavioural | Condition 10: Components 2 and 3, Condition 13: Components 3 and 4, Condition 14: Components 3, Condition 1: Components 1, 2,3 and 4, Condition 2: Components 1, 2 and 3, Condition 5: Components 1,3 and 4, Condition 6: Components 1 and 3, Condition 9: Components 2,3 and 4 |
| Engagement with HIV treatment-experienced role models who share lived experiences of HIVParticipants will be assigned to small groups with an average of 3-4 peers from the same health clinic, and each ALHIV stays in the same group -- for 9 sessions - with the same role model. This is intended to build trust and rapport not only between the role model and mentee, but also between all group members. The 9 sessions, to be conducted over a 6-month period, include activities, videos, scenarios, and role-playing to facilitate discussion and learning. This is intended to promote their self-esteem, improve their HIV care engagement, reduce stigma and stress, encourage hopefulness, build stronger communication skills with their caregivers and/or family members, enhance safe sexual decision-making, and decrease sexual risk-taking behavior. | Behavioural | Condition 11: Components 2 and 4, Condition 13: Components 3 and 4, Condition 15: Components 4, Condition 1: Components 1, 2,3 and 4, Condition 3: Components 1, 2 and 4, Condition 5: Components 1,3 and 4, Condition 7: Components 1 and 4, Condition 9: Components 2,3 and 4 |
| Standard of Care (SOC)SOC consisting of pediatric ART initiation and monitoring outlined by Uganda's Ministry of Health. | Other | Condition 16: No Components |
Primary outcome
Achievement of Viral Suppression
Time frame: Baseline 12, 24 and 36 month follow-up
Change in viral suppression will be assessed using viral load (VL) data collected from health clinic records. VL will be dichotomized between undetectable /suppression (VL< 40 copies/ml) and detectable/failed viral suppression (VL > =40 copies/ml) levels at each assessment time.
Cost-Effectiveness Analyses
Time frame: Baseline 12, 24 and 36 month follow-up
Cost-effectiveness analyses measuring the cost of achieving an agreed upon benefit, such as cost of staff time, supplies, overhead of IDA's, as measured by admin review and project records.
6 secondary outcomes
Financial Literacy
Time frame: Baseline 12, 24 and 36 month follow-up
Financial management skills
Time frame: Baseline 12, 24 and 36 month follow-up
Engagement with financial institutions
Time frame: Baseline 12, 24 and 36 month follow-up
Change in confidence to save
Time frame: Baseline 12, 24 and 36 month follow-up
Change in motivation to save
Time frame: Baseline 12, 24 and 36 month follow-up
Change in savings amount and Investment in IGA
Time frame: Baseline 12, 24 and 36 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Derived from this study: PubMed 37081534Ssewamala FM, Sauceda JA, Brathwaite R, Neilands TB, Nabunya P, Brown D, Sensoy Bahar O, Namuwonge F, Nakasujja N, Mugarura A, Mwebembezi A, Nartey P, Mukasa B, Gwadz M. Suubi + Adherence4Youth: a study protocol to optimize the Suubi Intervention for Adherence to HIV treatment for youth living with HIV in Uganda. BMC Public Health. 2023 Apr 20;23(1):717. doi: 10.1186/s12889-023-15564-4.
- Individual participant dataSharing planned: Yes. Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per Code of Federal Regulations Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Washington University in St. Louis' Office of Sponsored Projects' data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Literacy Training (FLT) Workshops, Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) and A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). in people with HIV, run by Washington University School of Medicine at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of Viral Suppression (time frame: Baseline 12, 24 and 36 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05600621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.